Correct input data to re-calculate results of 3x3x3 study using lm() [🇷 for BE/BA]

posted by VStus – Poland, 2016-09-12 10:41 (3203 d 06:59 ago) – Posting: # 16632
Views: 6,451

Dear BE-proff,

❝ As far as I understood you had studies with several dosages test products and the same reference. Correct? ;-)


Both studies were exploratory pilots to comparative bioavailability of different Test formulations having different in-vitro characteristics (modified release products) versus Reference formulation. Bioequivalence assessment was only supportive.

Test product was developed using different release mechanism than originator, in-vivo performance of different formulation tweaks were assessed based on obtained PK profiles versus in-vitro data.

Regards, VStus

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,673 registered users;
39 visitors (0 registered, 39 guests [including 12 identified bots]).
Forum time: 17:40 CEST (Europe/Vienna)

Complex, statistically improbable things are by their nature
more difficult to explain than
simple, statistically probable things.    Richard Dawkins

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5